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The Montefiore Metoclopramide Study

Information source: Montefiore Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Nausea; Extrapyramidal Symptoms

Intervention: metoclopramide 10 mg (Drug); Diphenhydramine 25 mg (Drug); Placebo (Drug); Metoclopramide 20 mg (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Montefiore Medical Center

Official(s) and/or principal investigator(s):
Benjamin W Friedman, MD, Principal Investigator, Affiliation: Montefiore Medical Center
Brooke Bender, MD, Study Director, Affiliation: Albert Einstein College of Medicine of Yeshiva University


Metoclopramide is a dopamine antagonist frequently used for the treatment of nausea, vomiting, and migraine headaches in Emergency Departments. However, little research has focused on the optimal dose of metoclopramide for treatment of nausea in the emergency department. We propose a randomized, double-blind, placebo controlled trial to investigate the optimal dose of metoclopramide for treatment of nausea.

Clinical Details

Official title: A Randomized, Facorial Design Study to Optimize the Dose of Parenteral Metoclopramide

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Nausea Scale

Secondary outcome: Number of Participants With Akathisia

Detailed description: The most effective dose of metoclopramide for treatment of nausea in the emergency department setting has not been thoroughly investigated. One pilot study among emergency department patients in Australia found no statistical difference between 10 mg and 0. 4 milligrams/kilogram; another investigation suggests that the anti-emetic effect of 10 milligrams of metoclopramide is no more effective than placebo. In contrast, investigations focusing on chemotherapy patients and post-operative patients suggest that higher dosage metoclopramide is more effective in treating nausea and vomiting. This emergency department study will compare the anti-emetic efficacy of 10 milligrams and 20 milligrams of metoclopramide by using the visual analog scale. In addition to evaluation of dose, we will evaluate one of the most common side affects of metoclopramide, akathisia. Akathisia is characterized by a subjective component of restlessness and an objective component in the form of the inability to remain motionless. Anti-cholinergic medications are known to reduce extrapyramidal symptoms such as akathisia when dopamine function is impaired in the basal ganglia. In fact, the use of diphenhydramine has been shown to reduce the incidence of akathisia in patients receiving a different anti-emetic, prochlorperazine. However, no research has focused on the use of anti-cholinergic medications to reduce metoclopramide induced akathisia. This investigation will assess the use of 25 mg of diphenhydramine in preventing metoclopramide induced akathisia in ED patients being treated for nausea/vomiting.


Minimum age: 21 Years. Maximum age: 65 Years. Gender(s): Both.


Inclusion Criteria:

- primary or secondary complaints of nausea/vomiting

- age 21-65

Exclusion Criteria:

- pregnancy

- use of anti-histamine or dopamine antagonist as outpatient and/or within last 24

hours of presentation

- previous adverse reaction to study medications

- use of opioid medications prior to study start time within that ED visit

Locations and Contacts

Montefiore Medical Center, Bronx, New York 10461, United States
Additional Information

Starting date: May 2007
Last updated: November 28, 2012

Page last updated: August 23, 2015

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